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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, anticardiolipin immunological
510(k) Number K001574
Device Name DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
Applicant
AXIS-SHIELD
THE TECHNOLOGY PARK
JUNA PLACE
DUNDEE TAYSIDE, SCOTLAND,  GB DD2 1XA
Applicant Contact EILEEN A MCCAFFERTY
Correspondent
AXIS-SHIELD
THE TECHNOLOGY PARK
JUNA PLACE
DUNDEE TAYSIDE, SCOTLAND,  GB DD2 1XA
Correspondent Contact EILEEN A MCCAFFERTY
Regulation Number866.5660
Classification Product Code
MID  
Date Received05/22/2000
Decision Date 06/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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